Nicholas Mohtadi1, Rhamona Barber, Denise Chan, Elizabeth Oddone Paolucci. 1. *Sport Medicine Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada; and †Departments of Surgery and Community Health Sciences, Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada.
Abstract
OBJECTIVE:Complications/adverse events of anterior cruciate ligament (ACL) surgery are underreported, despite pooled level 1 data in systematic reviews. All adverse events/complications occurring within a 2-year postoperative period after primary ACL reconstruction, as part of a large randomized clinical trial (RCT), were identified and described. DESIGN: Prospective, double-blind randomized clinical trial. Patients and the independent trained examiner were blinded to treatment allocation. SETTING:University-based orthopedic referral practice. PATIENTS: Three hundred thirty patients (14-50 years; 183 males) with isolated ACL deficiency were intraoperatively randomized to ACL reconstruction with 1 autograft type. Graft harvest and arthroscopic portal incisions were identical. INTERVENTION: Patients were equally distributed to patellar tendon (PT), quadruple-stranded hamstring tendon (HT), and double-bundle (DB) hamstring autograft ACL reconstruction. MAIN OUTCOME MEASURES: Adverse events/complications were patient reported, documented, and diagnoses confirmed. RESULTS: Two major complications occurred: pulmonary embolism and septic arthritis. Twenty-four patients (7.3%) required repeat surgery, including 25 separate operations: PT = 7 (6.4%), HT = 9 (8.2%), and DB = 8 (7.3%). Repeat surgery was performed for meniscal tears (3.6%; n = 12), intra-articular scarring (2.7%; n = 9), chondral pathology (0.6%; n = 2), and wound dehiscence (0.3%; n = 1). Other complications included wound problems, sensory nerve damage, muscle tendon injury, tibial periostitis, and suspected meniscal tears and chondral lesions. Overall, more complications occurred in the HT/DB groups (PT = 24; HT = 31; DB = 45), but more PT patients complained of moderate or severe kneeling pain (PT = 17; HT = 9; DB = 4) at 2 years. CONCLUSIONS: Overall, ACL reconstructive surgery is safe. Major complications were uncommon. Secondary surgery was necessary 7.3% of the time for complications/adverse events (excluding graft reinjury or revisions) within the first 2 years. LEVEL OF EVIDENCE: Level 1 (therapeutic studies). CLINICAL RELEVANCE: This article reports on the complications/adverse events that were prospectively identified up to 2 years postoperatively, in a defined patient population participating in a large double-blind randomized clinical trial comparing PT, single-bundle hamstring, and DB hamstring reconstructions for ACL rupture.
RCT Entities:
OBJECTIVE: Complications/adverse events of anterior cruciate ligament (ACL) surgery are underreported, despite pooled level 1 data in systematic reviews. All adverse events/complications occurring within a 2-year postoperative period after primary ACL reconstruction, as part of a large randomized clinical trial (RCT), were identified and described. DESIGN: Prospective, double-blind randomized clinical trial. Patients and the independent trained examiner were blinded to treatment allocation. SETTING: University-based orthopedic referral practice. PATIENTS: Three hundred thirty patients (14-50 years; 183 males) with isolated ACL deficiency were intraoperatively randomized to ACL reconstruction with 1 autograft type. Graft harvest and arthroscopic portal incisions were identical. INTERVENTION: Patients were equally distributed to patellar tendon (PT), quadruple-stranded hamstring tendon (HT), and double-bundle (DB) hamstring autograft ACL reconstruction. MAIN OUTCOME MEASURES: Adverse events/complications were patient reported, documented, and diagnoses confirmed. RESULTS: Two major complications occurred: pulmonary embolism and septic arthritis. Twenty-four patients (7.3%) required repeat surgery, including 25 separate operations: PT = 7 (6.4%), HT = 9 (8.2%), and DB = 8 (7.3%). Repeat surgery was performed for meniscal tears (3.6%; n = 12), intra-articular scarring (2.7%; n = 9), chondral pathology (0.6%; n = 2), and wound dehiscence (0.3%; n = 1). Other complications included wound problems, sensory nerve damage, muscle tendon injury, tibial periostitis, and suspected meniscal tears and chondral lesions. Overall, more complications occurred in the HT/DB groups (PT = 24; HT = 31; DB = 45), but more PT patients complained of moderate or severe kneeling pain (PT = 17; HT = 9; DB = 4) at 2 years. CONCLUSIONS: Overall, ACL reconstructive surgery is safe. Major complications were uncommon. Secondary surgery was necessary 7.3% of the time for complications/adverse events (excluding graft reinjury or revisions) within the first 2 years. LEVEL OF EVIDENCE: Level 1 (therapeutic studies). CLINICAL RELEVANCE: This article reports on the complications/adverse events that were prospectively identified up to 2 years postoperatively, in a defined patient population participating in a large double-blind randomized clinical trial comparing PT, single-bundle hamstring, and DB hamstring reconstructions for ACL rupture.
Authors: Brandon J Erickson; Peter N Chalmers; Jeffrey R Dugas; Bernard R Bach; Gregory P Nicholson; Nikhil N Verma; Christopher S Ahmad; Anthony A Romeo Journal: Orthop J Sports Med Date: 2017-07-03
Authors: Anthony C Mok; Andrew J Fancher; Matthew L Vopat; Jordan Baker; Armin Tarakemeh; Scott Mullen; John P Schroeppel; Kim Templeton; Mary K Mulcahey; Bryan G Vopat Journal: Orthop J Sports Med Date: 2022-02-23